丁力承 金德庄 李香玉

    摘 要 嵌合抗原受体T细胞治疗产品的上市，标志着个体化治疗进入了一个新阶段。但因该类产品生产工艺复杂，相关产业链尚未真正成熟，而此产业现又处在快速发展的上升阶段，整个业界存在一定的人才缺口，对产品上市后的质量管理和监管提出了挑战。本文从嵌合抗原受体T细胞治疗产品的特点出发，分析该类产品在防混淆、防污染方面面临的问题，以期业界加强质量管理，确保产品质量和安全。

    关键词 嵌合抗原受体T细胞 质量管理 药品监管

    中图分类号：R951； R979.19 文献标志码：C 文章编号：1006-1533(2022)11-0011-03

    引用本文 丁力承， 金德庄， 李香玉. 浅论嵌合抗原受体T细胞治疗产品的防混淆、防污染挑战[J]. 上海医药， 2022， 43(11)： 11-13.

    Discussion on the challenge to prevent chimeric antigen receptor T cell therapy products from mix-up and contamination

    DING Licheng， JIN Dezhuang， LI Xiangyu

    (Shanghai Center for Drug Evaluation and Inspection， Shanghai 201203， China)

    ABSTRACT The marketing authorization of chimeric antigen receptor T cell (CAR-T) therapy products marks that the individualized therapy has entered a new stage. However， the relevant industrial chain has not really matured due to the complex production process of such products. Although this industry is now in the rising stage of rapid development， the whole industry poses a challenge to the quality management and supervision of products after marketing because there exists a certain talent gap. This paper analyzes the problems faced by these products to be prevented from mix-up and contamination so as to strengthen the quality management and ensure the product quality and safety based on the characteristics of CAR-T therapy products. ......